USP 797/800 Compliance
In 2005, USP 797 will require (these are regulations, not guidelines) a cleaner environment for health care institutions, pharmacies, physicians practice facilities and other facilities where compounded sterile preparations are prepared, stored and dispensed. NCI can assist you by providing the components and equipment that will assure your compliance with these regulations.
Currently, compounding is required to be done entirely with ISO Class 5 (Class 100) or better air quality. Facilities currently doing such compounding have such equipment, however, if you do not have a unit, please see our CAP 301 "Horizontal Flow Clean Bench" listed below. NCI will be happy to give you the expert information needed to provide your facility the right equipment. This, however, is not all that is required under the new USP 797 regulation. A cleaner environment is needed. There are two avenues that can be taken to accomplish this.
The first option is a Class ISO 5 (Class 100) laminar flow Barrier Isolator. This is an enclosed laminar flow glove box with attached gloves, where the operator stands outside of the viewscreen. The operator puts their hands into the attached gloves and manipulates the compounding products within that enclosure.
The advantages to such a unit is that it does not require a cleanroom and therefore may take less space. The unit is also applicable for Low, Medium and High risk conditions. For facilities that work with potential carcinogenic, mutagenic and/or teratogenic agents, a Chemo Hood (a more protective unit) is required. This type of hood also protects the operator from aerosols generated from the preparation of chemotherapeutics.
The disadvantages are that the enclosure is cumbersome to work in. The gloves which are attached to the box are generally heavy since they are semi-permanent and the movement is somewhat restricted. The unit is also restricted to one or two operators. Additional usage requires additional equipment which are costlier than additional horizontal flow units. If your facility currently uses a non-enclosed Class ISO 5 (Class 100) unit, there is the cost of equipment replacement as opposed to a possible lower cost to construct a cleanroom.
The second option is the addition of a cleanroom. A cleanroom is a contained area with a laminar flow of HEPA filtered air with enough positive pressure to attain a pre-determined level of cleanliness. In the case of USP 797, the level that needs to surround the Class ISO 5 (Class 100) laminar flow unit is Class ISO 8 (Class 100,000).
The advantages of a cleanroom are that it gives the operator more freedom of movement. The cleanroom can be large enough to accommodate a large staff as well as more equipment and supplies. The cost to build a cleanroom, especially a Class ISO 8 (Class 100,000) is relatively low. Below are a variety of options NCI can provide, from enclosing the corner of a room to a large scale, hard wall cleanroom. (See "A Primer on Cleanrooms ")
The disadvantages is that a cleanroom may take more space than a laminar flow glovebox. If your facility has no compound preparation taking place currently, the cost for a cleanroom and a laminar flow Class ISO 5 (Class 100) may be more than a laminar flow glovebox, but that is not necessarily true in all cases. Finally, a cleanroom takes some additional care for cleaning since it requires supplies and solutions that are low in particulants. Regardless, those low particulant items are also needed for the cleaning of Isolation Barriers (see A Primer on Equipment and Supplies).
Please see our Cleanroom Information page for suggestions or Contact NCI for Information to fit Your Cleanroom Specifications!
More information on the USP's Latest Standards Updates can be found at www.usp.org.